FDA product code NIY: Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
NIY is the FDA product code for autoantibodies, anti-soluble liver antigen (sla), autoimmune hepatitis. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under NIY, from 2 different applicants. The average 510(k) review took 332 days (median 406).
Definition
ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis
Classification
| Field | Value |
|---|---|
| Device name | Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NIY clearance
Top NIY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Euroimmun US | 2 | 2013-04-12 |
| Inova Diagnostics, Inc. | 1 | 2002-07-30 |
Most recent NIY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113439 | Euroimmun US | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) | 2013-04-12 | 508 |
| K112221 | Euroimmun US | EUROIMMUN ANTI-SLA/LP ELISA(LGG) | 2012-09-11 | 406 |
| K021482 | Inova Diagnostics, Inc. | QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA | 2002-07-30 | 83 |
Recalls for NIY devices
openFDA lists no recalls for product code NIY.
Frequently asked questions
What is FDA product code NIY?
NIY is the FDA product code for autoantibodies, anti-soluble liver antigen (sla), autoimmune hepatitis. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is NIY?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code NIY?
Across 3 cleared submissions the average was 332 days from receipt to decision (median 406).
Which companies have the most NIY clearances?
Euroimmun US (2); Inova Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NIY
- Run a recall and safety report across every NIY manufacturer
- Watch product code NIY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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